RecruitingPhase 2Phase 3NCT05833815

Addition of Everolimus to Standard of Care in Carcinoma Gallbladder

A Randomized Controlled, Open Labeled, Two Arm, Study of Addition of Everolimus to Standard of Care in Carcinoma Gallbladder


Sponsor

Banaras Hindu University

Enrollment

56 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Gallbladder cancer (GBC) is the most common malignant tumour of the biliary tract. It is also the most aggressive cancer of the biliary tract with the shortest median survival from the time of diagnosis. Currently, radical resection is the most effective strategy to potentially cure GBC. Chemotherapy and radiotherapy have been employed as adjuvant and palliative setting, however, the overall survival is still dismal. This study aim to evaluate the addition of Everolimus in addition to standard of care in gallbladder cancer.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding everolimus (a targeted drug that blocks cancer cell growth) to standard chemotherapy improves outcomes for patients with advanced gallbladder cancer that cannot be surgically removed. Gallbladder cancer is rare and often diagnosed at a late stage, so researchers are looking for more effective treatments. **You may be eligible if...** - You have been diagnosed with advanced (stage III or IV) gallbladder cancer that cannot be removed surgically - You have not yet received chemotherapy for advanced disease (or received it more than 6 months ago as a preventive measure after surgery) - Your blood counts, liver, and kidney function meet required levels - Your blood sugar is not severely elevated - Your general health allows participation (ECOG score 0–2) **You may NOT be eligible if...** - You have uncontrolled infections, heart failure, or unstable angina - You had a heart attack within the last 6 months - You are pregnant - You are using medications that cannot be safely combined with the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEverolimus 10 mg

Oral Everolimus 10 mg daily in addition to standard of care i.e. GemOx or CapOx

DRUGStandard of care

GemOx or CapOx


Locations(1)

Banaras Hindu University

Varanasi, Uttar Pradesh, India

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NCT05833815


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